Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI
Summary
The FDA issued a Class II for Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 586 by GE Medical Systems Information Technologies Inc. Reason: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinical.
Details
Source
Device Recall
External ID
Z-3143-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Lot/Code Info: 5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU 5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU 5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV
Quantity Affected: 29,570 (23,632 US; 5,938 OUS)
Reason for Recall
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-30
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
GE Medical Systems Information Technologies Inc has 31 FDA actions in our database, including 18 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems Information Technologies Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems Information Technologies Inc have FDA actions?
GE Medical Systems Information Technologies Inc has 31 FDA actions in our database, including 18 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3143-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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